ImmunityBio Announces HIV Clinical Pipeline with Opening of a Phase 1 ‘HIV Cure Study’ in Patients Off Therapy and a Phase 2 Study in Acutely Infected Patients
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Sponsored by the
NIAID and AIDS Clinical Trials Group , an “HIV cure study” will evaluate whether IL-15 superagonist AnktivaÔ (N-803) alone or together with broadly neutralizing antibodies can control HIV following interruption of antiretroviral therapy (ART). - The Phase 1 open-label, randomized study will enroll 46 people living with HIV whose virus has been suppressed by ART for approximately two years, including at least 30 percent cisgender women or transgender men.
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A second clinical trial studying Anktiva in HIV is being conducted by the
U.S. Military HIV Research Program inThailand . The Phase 2 study is evaluating Anktiva in combination with antiretroviral therapy (ART) during acute HIV infection as an experimental therapy to target and inhibit early establishment of HIV reservoirs in infected individuals.
The second study, which was announced earlier this year and is in Phase 2, will evaluate Anktiva in combination with antiretroviral therapy during acute HIV infection. This study is being conducted by the
In both pre-clinical and clinical research, ImmunityBio’s IL-15 superagonist Anktiva has exhibited three activities that could potentially help the immune system to eliminate HIV reservoirs or to control virus rebound. First, Anktiva has been shown to reverse HIV latency—by activating HIV replication within long-lived cells in the immune system thus allowing the infected cells to be recognized and cleared by the immune system. Second, it activates natural killer (NK) cells and CD8+ T-cells, two elements of the immune system that specialize in killing virus-infected cells. Finally, it enables NK cells and CD8+ T-cells to move to lymphoid tissues where they will encounter and hopefully eliminate HIV-infected cells.
The actions of bNAbs (or antibodies that neutralize a broad number of variants of HIV) are well-matched to that of Anktiva. bNAbs can neutralize HIV that is produced upon reactivation, preventing new infections; target (label) HIV-infected cells for destruction by NK cells; and may act to boost CD8+ T-cell responses. The ACTG study (A5386) will use an array of virologic and immunologic tests to evaluate the degree to which each of these expected activities is induced in study participants. Ultimately, the study will test whether this approach results in immune control of HIV when ART is paused, with careful monitoring.
“An estimated 38 million people globally are living with HIV and the majority of these individuals reside in low- and middle-income countries that are contending with strained healthcare budgets. The current standard of care for HIV is the use of antiretroviral drugs that can be expensive and must be taken for a patient’s lifetime. While these antiretroviral therapies developed over the last several years are helping many people with HIV live longer, healthier lives, we still lack a cure,” said
A5386 Study Details:
A5386 is a Phase 1, open-label, randomized study evaluating the safety, tolerability, and efficacy of N-803 both with and without combination bNAbs. It will enroll 46 people living with HIV (23 in each study arm) whose virus has been suppressed by ART for approximately two years, including at least 30 percent cisgender women or transgender men. Participants will undergo leukapheresis (a medical procedure in which white blood cells, or leukocytes, are separated from the blood) to measure their HIV reservoirs and a subset will undergo optional lymph node fine needle aspirations to assess the effect of N-803 on lymphoid tissue. They will then be randomized to one of two arms: N-803 alone or N-803 with combination bNAbs. After receiving treatment, participants will stop taking ART and will be followed closely to monitor for signs that they need to restart ART. Most participants will be followed for approximately 100 weeks after receiving treatment.
A5386 is led by
“Living with HIV means taking medication lifelong. We hope this study will be an important step towards controlling HIV without this need,” said
NCT04505501 Study Details:
The MHRP-sponsored clinical study is designed to investigate the safety, tolerability and immunostimulatory effects of Anktiva administration during acute HIV infection. Anktiva will be administered subcutaneously at weeks zero, three and six and it will be used along with antiretroviral therapy (ART) to determine whether Anktiva’s immunostimulatory effects reduce HIV titers during the acute stage of infection. The study duration is 12 weeks and will enroll 15 participants.
About the ACTG
Founded in 1987, the
About
The company’s platforms are based on the foundation of four separate modalities: Antibody cytokine fusion proteins, synthetic immunomodulators, second-generation human adenovirus (hAd5) and yeast vaccine technologies, and state-of-the-art, off-the-shelf natural killer cells, including autologous and allogenic cytokine-enhanced memory NK cells.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as “anticipates,” “believes,” “continues”, “could”, “estimates,” “expects,” “intends,” “may,” “plans,” “potential”, “predicts”, “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. These forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio’s management as well as assumptions made by and information currently available to
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